November 2023 Brief

The approval of pembrolizumab with gemcitabine and cisplatin offers a new immunotherapy regimen for patients with locally advanced unresectable or metastatic biliary tract cancer.

With a partial clinical hold in place, patient enrollment must halt in the phase 1 NX-2127-001 trial.

Rhenium obisbemeda shows potential to address the unmet need of new treatment options for patients with breast cancer and leptomeningeal metastases and will continue to be evaluated in the ReSPECT-LM program.

With an investigational new drug granted to ZH9 by the FDA, a clinical development program for the treatment of patients with non-muscle invasive bladder cancer can be initiated.

Data from the phase 2 of the RINGSIDE trial have led the FDA to grant an orphan drug designation to AL102 as a potential therapeutic option for patients with desmoid tumors.

Fruquintinib is a new, well-tolerated option for the treatment of patients with refractory metastatic colorectal cancer.

The updated indication limits the use of pembrolizumab and chemotherapy to tumors expressing PD-L1 as determined by an FDA-approved test.

The application for lisocabtagene maraleucel in relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma has been accepted by the FDA, following positive results from the TRANSCEND CLL 004 study.

THIO has received 2 prior orphan drug designations, and the agent has shown promise in preclinical studies for the treatment of glioblastoma.

A phase 1/2 trial is evaluating the safety, efficacy, and tolerability of RZ-001 in patients with glioblastoma.

This companion diagnostic tool, which is already approved for use in 5 other cancer types, identifies patients who may be suited for treatment with pembrolizumab.

The fast track designation granted to SONALA-001 in combination with the INSIGHTEC Exablate 4000 Type-2 Device from the FDA is for the treatment of patients with diffuse intrinsic pontine glioma.

Following the FDA’s denial of a de novo classification request of ProSense, citing concerns about the choice of comparator group used in the ICE3 trial, IceCure is working to identify a more representative comparator group.

SIRPant-M has been granted orphan drug designation by the FDA for patients with T-cell lymphoma.

Repotrectinib is now an FDA-approved option for patients with ROS1- positive advanced non-small cell lung cancer.

The FDA’s Oncologic Drugs Advisory Committee discussed delays that can occur when drugs are granted accelerated approval, and the post-approval confirmatory trials of pralatrexate and belinostat for peripheral T-cell lymphoma.

Pembrolizumab and fluoropyrimidine- and platinum-containing chemotherapy are now FDA-approved for the treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

The FDA has approved capivasertib with fulvestrant for adult patients with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer harboring 1 or more PIK3CA, AKT1, or PTEN alterations.

Enzalutamide is the first and only androgen receptor signaling inhibitor approved by the FDA in this intent-to-treat population.

Positive findings from the MARIPOSA-2 study of amivantamab with chemotherapy with or without lazertinib in locally advanced or metastatic non–small cell lung cancer with EGFR mutations support the submission of a supplemental biologics license application to the FDA.

In addition to the approval of capivasertib and fulvestrant, the FDA has granted approval to the FoundationOne® CDx as a companion diagnostic to identify patients with advanced HR-positive, HER2-negative advanced breast cancer.

Neal Shore, MD, FACS, discussed the phase 3 EMBARK trial and what the FDA approval of enzalutamide means for the prostate cancer treatment landscape.

An investigational new drug application for TCB008 has been cleared by the FDA. A phase 1B trial will now assess the agent in patients with relapsed/refractory acute myeloid leukemia.

The FDA breakthrough drug designation for epcoritamab in follicular lymphoma was supported by findings from the phase 1/2 EPCORE NHL-1 study.

The biologics license application seeking the approval of obe-cel as a potential therapeutic option in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia has been submitted to the FDA.

Nirogacestat is now an FDA-approved option for adult patients with progressing desmoid tumors who require systemic treatment.

Olvimulogene nanivacirepvec, an oncolytic viral-based therapy, has earned a fast track designation from the FDA in ovarian cancer resistant or refractory to platinum-based chemotherapy.

A fast track designation has been granted to zotatifin with fulvestrant, and abemaciclib for adult patients with estrogen receptor-positive/HER2-negative advanced or metastatic breast cancer.

CT-0525 is an ex vivo gene-modified autologous CAR-monocyte cellular therapy being evaluated for the treatment of HER2-overexpressing solid tumors.

A phase 1/2 study of KSQ-001EX will commence at MD Anderson Cancer Center following this investigational new drug approval from the FDA.

The investigation follows reports of T-cell malignancies after treatment with chimeric antigen receptor T-cell immunotherapies.

Positive data from the phase 3 EV-302 trial of enfortumab vedotin with pembrolizumab in locally advanced or metastatic urothelial cancer have shifted the landscape.

Here is a look back at the FDA happenings from the month of November 2023.